BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04332

    MDR report key: 5148348 · Received October 14, 2015

    Report

    Report Number
    1823260-2015-04332
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 20, 2015
    Report Date
    October 30, 2015
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED. BASED ON THE AVAILABLE DATA, THE POSSIBLE ROOT CAUSE MAY BE RELATED TO IMPROPER PRE-ANALYTIC CONDITIONS (INSUFFICIENT CLOTTING TIME, CENTRIFUGATION).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT TESTED FOR INTACT HUMAN CHORIONIC GONADOTROPIN + THE B-SUBUNIT (HCG + B). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL HCG + B RESULT FROM AN ALIQUOT FROM THE RSA PRO WAS 534 IU/L ON THE E602 ANALYZER. A 2ND SAMPLE WAS OBTAINED AND THE RESULT FROM AN ALIQUOT WAS 0 IU/L. A 3RD SAMPLE WAS OBTAINED AND THE RESULT WAS 0 IU/L. THE INITIAL AND 2ND SAMPLES WERE REPEATED AND THE RESULTS WERE 0 IU/L. NO ADVERSE EVENT WAS REPORTED. THE HCG + B REAGENT LOT NUMBER WAS 183183. THE EXPIRATION DATE WAS NOT PROVIDED. THE LAST CALIBRATION PERFORMED ON (B)(6) 2015 WAS ACCEPTABLE. IT WAS NOTED THAT RE-CALIBRATION WAS OVERDUE BY 3 MONTHS. QUALITY CONTROLS FROM (B)(6) 2015 WERE ACCEPTABLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 025 YR